510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201089Substantially Equivalent

ARK Lacosamide Assay

Ark Diagnostics Inc, Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201089 is the FDA 510(k) clearance record for ARK Lacosamide Assay, a class II device, cleared for Ark Diagnostics, Inc. on under FDA product code NWM (Immunoassay, Anti-Seizure Drug). FDA's definition for product code NWM reads: "To aid in management of patients treated with anti-seizure drug". FDA records list 17 510(k) clearances for Ark Diagnostics, Inc., from to . As of , FDA records show no recalls naming K201089.

Clearance record

Decision date
Received
(469 days to decision)
Product code
NWM Immunoassay, Anti-Seizure Drug
Regulation
21 CFR 862.3350
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Ark Diagnostics, Inc. 48089 Fremont Blvd., Fremont CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NWM

Trailing 12 months

FDA records hold no clearances under product code NWM in the trailing twelve months.

FDA records show no clearances under product code NWM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NWM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260